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临床试验/NCT00480662
NCT00480662已完成3 期

A 6-Month, Multicenter, Double-Blind, Randomized, Active-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Alendronate 280-mg Oral Buffered Solution Once Weekly in Patients With Paget's Disease of Bone

Organon and Co0 个研究点目标入组 60 人开始时间: 2001年10月最近更新:
适应症
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
60
主要终点
Patients will have a decrease of at least 30% in their blood alkaline phosphatase level after 6 months

研究概览

简要总结

To test the safety, effectiveness of MK0217 when taken once a week for six months in treating patients with Paget's bone disease.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female, ages 18 to 90 years with a diagnosis of Paget's bone disease

排除标准

  • Patient cannot stand or sit upright for at least 30 minutes
  • Patient has difficulty swallowing or problems with digestive system

结局指标

主要结局

Patients will have a decrease of at least 30% in their blood alkaline phosphatase level after 6 months

次要结局

  • MK0217 will be safely tolerated

研究者

申办方类型
Industry
责任方
Sponsor

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